Wednesday, December 17, 2014

Indicted Drug Compounder Shipped Other Drugs to Health Care Facilities

By Walter F. Roche Jr.

The long awaited indictment from a probe of a nationwide fungal meningitis outbreak shows that there may be even more victims of the now defunct drug compounding firm already officially blamed for 64 deaths and 751 illnesses in 20 states.
The 73-page indictment made public in Boston Wednesday states that additional injectable drugs were shipped from the New England Compounding Center even though testing showed they were not sterile.
The 2012 outbreak has been linked to fungus tainted vials of a single spinal steroid, methylprednisolone acetate, which is generally injected into the spine, neck or joints.
According to the indictment those other drugs include cardioplegia, a drug used during cardiac surgery to slow or stop the heart from beating, bags of potassium chloride and bacitracin. All were injectable drugs that were supposed to be sterile but weren't, the indictment charges.
And the grand jury found that those unsterile drugs were shipped to health facilities in states not previously implicated in the 2012 fungal meningitis outbreak.
For instance bacitracin syringes were  shipped to a hospital in Illinois and other injectables were shipped to a Glens Falls, N.Y. hospital despite failing tests for sterility. Cardioplegia found not sterile was shipped to Brigham and Women's Hospital in Boston, the indictment states. Injectable drugs made from expired components were shipped to the USC University Hospital in Los Angeles, Calif.
Already there are at least two pending federal suits blaming the deaths of two children at a Las Vegas hospital on tainted cardioplegia injections from NECC.
The defendants, the indictment charges, acted "in a manner inherently dangerous to human life."
The 131-count indictment charges  NECC owner Barry Cadden and its chief pharmacist, Glenn A. Chin, with 2nd degree murder in the deaths of 25 patients in seven states, including Tennessee, Michigan, Virginia and Indiana.
Ten others charged include Cadden's partners in the Framingham, Mass. business and former employees of the now defunct compounding firm.
The charges include racketeering, creating fraudulent prescriptions for patients and multiple violations of state and federal drug statutes and regulations.
According to the indictment, the faked prescriptions listed names like Big Baby Jesus, Mickey Mouse and Flash Gordon. Those names were used despite warnings to NECC salesmen not to use obvious faked names.
NECC officials, the indictment charges, lied repeatedly to state and federal regulators to conceal the fact that they were not in compliance with laws and regulations, including a requirement that before drugs could be compounded a prescription had to be issued in an individual patient's name.
The indictment also charges that Douglas and Carla Conigliaro, who are relatives and partners of Cadden, violated a temporary restraining order issued in a related bankruptcy case by withdrawing $33.3 million from bank and investment accounts over the past 18 months.
The indictment charges that they attempted to hide their actions by keeping multiple withdrawals below the amount which would have triggered an automatic report to the federal government.
Another defendant, Gregory Conigliaro, recently transferred more than $1 million of his interest in real estate to his wife.
Among the NECC employees indicted was Scott M Connolly, who had voluntarily surrendered his license as a pharmacy technician years earlier yet continued to compound drugs for NECC until the facility was shut down in the Fall of 2012.
The indictments, which come more than two years after the outbreak was first reported, are providing at least some relief to the living victims.
Joan Peay, one of several Tennessee victims said she was "very relieved and grateful to know that these criminals will be prosecuted. These are truly criminals," she added. "I hope they (federal officials) find and take even more of their assets."
Under a pending plan filed in U.S. Bankruptcy Court in Massachusetts about $135 million would be available for victims and their survivors. That total includes nearly $50 million from NECC's owners.
Lawyers for the victims, including Mark Chalos of Nashville, said they were hopeful additional assets would be made available.


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